PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems R3.0. Includes the following label descriptions and correspondi…

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

Philips notified consignees on about 12/08/2025 via emailed URGENT Medical Device Correction letter. The letter informed consignees that they have identified nine (9) software issues affecting Azurion R3.0 systems that may result in loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data. Consignees were instructed to identify all affected units on hand, ensure all users of the affected units are aware of the issue and notify any customers if the unit has been transferred or distributed. Consignees were also instructed to keep the notification with documentation of the system until the issue is resolved, and complete and return the response form. If any of the nine issues are encountered, consignees were asked to contact their local Philips representative and the letter provided recommended actions. Philips will address the identified issues by implementing software updates in all affected systems. Philips expects to have software update 3.1.5 (FCO72200613), that resolves issues 1 - 7, released by Q1 2026 (subject to regulatory clearance). The Misalignment of Marker Tool Overlay (issue 8) and Longitudinal Position Error (issue 9) will not be resolved with software update 3.1.5. The solution for those issues is planned for Q4 2026 (subject to regulatory clearance) with software update 3.1.15 (FC072200684). Local Philips representatives will contact each consignee to schedule visits to install the software updates once available.

• FDA enforcement recordOfficial FDA database entry for Z-1079-2026
• FDA 510(k) clearance · K200917The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.